Health care providers in the United States have entered a new competitive era. Changes in government reimbursement policies have limited the amount of money that is paid for medical care. Payment of flat fees, based on Diagnostic Related Groups (DRGs), has effectively limited hospital and laboratory charges. Support of Health Maintenance Organizations and similar prepaid medical plans has created new health-care organizations to compete with traditional providers. The new competitive marketplace puts pressure on a provider not only to reduce the costs of products and services but also, and at the same time, to improve their quality, to maintain or increase their share of the market. The effect on clinical laboratories is that performing more tests no longer guarantees more revenue or increased resources to support new tests and services. In addition, the quality of the laboratory's testing services that employ complex analytical processes, and their usefulness to the physician and patient must be at least maintained and, in many cases, improved.
In general, an analytical process includes a measurement procedure and a control procedure. The measurement procedure refers to the analytical method per se, i.e., the reagents, the instrument, and the step-by-step directions for producing an analytical result. The control procedure refers to that part of the process concerned with testing the validity of the analytical result to determine whether it is reliable and can be reported. The development and theoretical aspects of a control procedure are discussed, for example, by Westgard and Barry (Westgard, J. O. and Barry, P. L., Cost-Effective Quality Control: Manage the quality and productivity of analytical processes, AACC Press, Washington, DC (1986)).
Improvements in an analytical process translate into reduced costs, higher productivity and improved quality of analysis for an implementing laboratory. In today's competitive environment, laboratories which focus on improvements in such analytical processes are at a competitive advantage relative to those which do not.